The Biostatistics Facility is a shared institutional resource for biostatistical collaboration and related methodological research. It is recognized as an important aspect of the research infrastructure at the Fox Chase Cancer Center (FCCC). The Facility serves as a focal point from which the Center's investigators may draw statistical expertise for planning, management, and analysis of their studies. This effort spans all three FCCC Divisions and 10 Research Programs. Between January 2000 and June 2004, Facility biostatisticians were involved in the publication of 139 papers and in the design of 261 in-house clinical protocols. During the current funding cycle, this Core has actively served the needs of 69 investigators with peer-reviewed funding on statistical issues concerning their research projects. The Facility was rated "Outstanding" at the last CCSG review. In 2003 the Facility logged 5,464 consulting hours with 91% in support of investigators with peer-reviewed funding. The specific aims of the Biostatistics Facility are: (1) Coordinate and manage statistical activities in the Cancer Center to ensure that every investigator has ready access to statistical consultation and support. (2) Provide statistical expertise in the design of experiments and studies, including research proposal development, sample size determination, randomization procedures, and plans for interim reviews and final analysis. (3) Provide statistical analysis for Cancer Center projects using appropriate statistical and computing methodologies, assist in the interpretation and presentation of results. (4) Provide statistical components for manuscripts. (5) Review, in conjunction with the Scientific Review Committee, the integrity and statistical soundness of all studies involving human subjects. (6) Interact and collaborate with the Population Studies Facility to ensure the retrieval of relevant and valid data. (7) Interact and collaborate with the Protocol Office in the development of protocols and the monitoring and reporting of clinical data. (8) Maintain a library of up-to-date software for statistical analysis. (9) When necessary, develop specialized methods that are clearly and closely related to the support of specific Cancer Center projects.